MDSAP nonconformity grading

MDSAP grades a nonconformity from 1 to 5 using quality-system impact and whether it is a first occurrence or a repeat, with escalation when the process is missing or nonconforming product was released.

Indirect impact on the quality system scores lower than direct impact. A first occurrence scores lower than a repeat. The grade steps up again when a required process is absent, or when product that did not conform was released. The result is a number from 1 to 5. Higher grades draw faster follow-up from the auditing organization. The official grading document is the authority for the matrix and for any timeline. This page does not print a number of days.

ISO 13485 reports often still say minor or major. MDSAP wants the grade as well. If your procedure uses both, write down how they meet so the closing meeting does not invent a conversion. In HAVGATE, put the task number on the finding, write the impact and the occurrence you used, and put the grade in the narrative if your procedure requires the number. The product's severity words are not a substitute for that arithmetic.